Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer (DUO-E)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04269200 |
Recruitment Status :
Recruiting
First Posted : February 13, 2020
Last Update Posted : March 25, 2021
|
Tracking Information | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | February 10, 2020 | ||||||||||||||
First Posted Date ICMJE | February 13, 2020 | ||||||||||||||
Last Update Posted Date | March 25, 2021 | ||||||||||||||
Actual Study Start Date ICMJE | May 21, 2020 | ||||||||||||||
Estimated Primary Completion Date | September 26, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: upto to 4 years ] Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)
|
||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer | ||||||||||||||
Official Title ICMJE | A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E) | ||||||||||||||
Brief Summary | A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. | ||||||||||||||
Detailed Description | This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer |
||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: double-blind, placebo-controlled Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
||||||||||||||
Condition ICMJE | Endometrial Neoplasms | ||||||||||||||
Intervention ICMJE |
|
||||||||||||||
Study Arms ICMJE |
|
||||||||||||||
Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||
Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
699 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | March 5, 2025 | ||||||||||||||
Estimated Primary Completion Date | September 26, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
stimulatory or co-inhibitor T-cell receptor other than anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. |
||||||||||||||
Sex/Gender ICMJE |
|
||||||||||||||
Ages ICMJE | 18 Years to 150 Years (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
|
||||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Brazil, Canada, China, Colombia, Estonia, Germany, Greece, Hong Kong, Hungary, India, Israel, Japan, Korea, Republic of, Lithuania, Mexico, Poland, Russian Federation, Singapore, United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04269200 | ||||||||||||||
Other Study ID Numbers ICMJE | D9311C00001 2019-004112-60 ( EudraCT Number ) GOG-3041 ( Other Identifier: Gynecologic Oncology Group(GOG) Foundation Inc ) ENGOT-EN10 ( Other Identifier: The European Network for Gynaecological Oncological Trial groups ) D9311C00001 ( Other Identifier: AZ DCode ) |
||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||||
Responsible Party | AstraZeneca | ||||||||||||||
Study Sponsor ICMJE | AstraZeneca | ||||||||||||||
Collaborators ICMJE |
|
||||||||||||||
Investigators ICMJE |
|
||||||||||||||
PRS Account | AstraZeneca | ||||||||||||||
Verification Date | March 2021 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |